NCT00629629

Brief Summary

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
7.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

March 5, 2008

Last Update Submit

October 10, 2022

Conditions

AnemiaBreast Feeding, ExclusiveOverweight and Obesity

Keywords

Health Plan ImplementationFeeding and Eating Disorders of ChildhoodBreastfeedingComplementary feedingMorbidityAnemiaPublic policy

Outcome Measures

Primary Outcomes (5)

  • Effectiveness of a nutrition advice programme in exclusive breastfeeding.

    Group difference in months of esclusive breastfeeding

    1 year

  • Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    1 year

  • Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    4 years

  • Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    8 years

  • Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    12 years

Secondary Outcomes (6)

  • Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.

    1 year

  • Effectiveness of a nutrition advice programme in nutritional status

    1 year

  • Effectiveness of a nutrition advice programme in nutritional status

    4 years

  • Effectiveness of a nutrition advice programme in nutritional status

    8 Years

  • Effectiveness of a nutrition advice programme in nutritional status

    12 Years

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Mothers in the intervention group received dietary advice based on Brazilian guidelines \["Ten steps for the healthy eating: Feeding guidelines for Brazilian children from birth to two years" \] during monthly home visits from 2 weeks to 6 months postpartum and then every 2 months thereafter until 1 y postpartum.

Behavioral: Dietary Advice

Control

NO INTERVENTION

Mothers in the control group received routine medical assistance without any involvement of the research team. The study staff provided no materials to mothers on the Control Arm.

Interventions

Dietary AdviceBEHAVIORAL

Step 1 - Provide Exclusive breastfeeding up to 6 mo. Step 2- After 6 mo, gradually introduce complementary foods and continue breastfeeding up to 2 y or more. Step 3 - Complementary foods should be given 3 times a day (cereals, beans, fruits, and vegetables) if the child is breastfed, and 5 times a day if not. Step 4- Mealtimes must be adjusted to the children's cues of hunger and satiety. Step 5: Foods should gradually get thicker up to the time when the child is able to eat a family meal. Complementary foods should not be liquefied. Step 6: A large variety of healthy foods should be given daily to guarantee the intake of different nutrients. Step 7: Different fruits and vegetables should be offered daily. Step 8: Sugar, sweets, soft drinks, salty snacks, cookies, and processed and fried foods must be avoided. Step 9: Good hygiene practices in food preparation and handling. Step 10: Adequate feeding during child illness.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborn infants with birth weight ≥ 2.500 g and gestational age ≥ 37 weeks were considered eligible for the study.

You may not qualify if:

  • HIV-positive mothers
  • Congenital malformation
  • Infants referred to intensive care unit
  • Multiple pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Household

São Leopoldo, Rio Grande do Sul, Brazil

Location

Related Publications (8)

  • Vitolo MR, Bortolini GA, Feldens CA, Drachler Mde L. [Impacts of the 10 Steps to Healthy Feeding in Infants: a randomized field trial]. Cad Saude Publica. 2005 Sep-Oct;21(5):1448-57. doi: 10.1590/s0102-311x2005000500018. Epub 2005 Sep 12. Portuguese.

    PMID: 16158151RESULT

  • Feldens CA, Vitolo MR, Drachler Mde L. A randomized trial of the effectiveness of home visits in preventing early childhood caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):215-23. doi: 10.1111/j.1600-0528.2006.00337.x.

    PMID: 17518968RESULT

  • Valmorbida JL, Sangalli CN, Leffa PS, Baratto PS, Rauber F, Mennella JA, Vitolo MR. Sodium Intake Tracked from Infancy and Salt Taste Preference during Adolescence: Follow-up of a Randomized Controlled Field Trial in Brazil. Curr Dev Nutr. 2022 Dec 22;7(1):100011. doi: 10.1016/j.cdnut.2022.100011. eCollection 2023 Jan.

    PMID: 37181123DERIVED

  • Vitolo MR, da Costa Louzada ML, Rauber F, Campagnolo PD. Risk factors for high blood pressure in low income children aged 3-4 years. Eur J Pediatr. 2013 Aug;172(8):1097-103. doi: 10.1007/s00431-013-2012-9. Epub 2013 May 1.

    PMID: 23636283DERIVED

  • Louzada ML, Campagnolo PD, Rauber F, Vitolo MR. Long-term effectiveness of maternal dietary counseling in a low-income population: a randomized field trial. Pediatrics. 2012 Jun;129(6):e1477-84. doi: 10.1542/peds.2011-3063. Epub 2012 May 7.

    PMID: 22566413DERIVED

  • Bortolini GA, Vitolo MR. The impact of systematic dietary counseling during the first year of life on prevalence rates of anemia and iron deficiency at 12-16 months. J Pediatr (Rio J). 2012 Jan-Feb;88(1):33-9. doi: 10.2223/JPED.2156. Epub 2011 Dec 7.

    PMID: 22159301DERIVED

  • Vitolo MR, Rauber F, Campagnolo PD, Feldens CA, Hoffman DJ. Maternal dietary counseling in the first year of life is associated with a higher healthy eating index in childhood. J Nutr. 2010 Nov;140(11):2002-7. doi: 10.3945/jn.110.125211. Epub 2010 Sep 15.

    PMID: 20844187DERIVED

  • Feldens CA, Giugliani ER, Duncan BB, Drachler Mde L, Vitolo MR. Long-term effectiveness of a nutritional program in reducing early childhood caries: a randomized trial. Community Dent Oral Epidemiol. 2010 Aug;38(4):324-32. doi: 10.1111/j.1600-0528.2010.00540.x. Epub 2010 Apr 7.

    PMID: 20406273DERIVED

MeSH Terms

Conditions

AnemiaBreast FeedingOverweightObesityFeeding and Eating Disorders of Childhood

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesFeeding BehaviorBehaviorOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Márcia R Vitolo, PhD

    Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 6, 2008

Study Start

October 1, 2001

Primary Completion

October 1, 2002

Study Completion

May 1, 2015

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

BR(1)